MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number 24620

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reocclusion (1985)

Event Date 09/11/2018

Event Type  Injury  

Event Description

It was reported the patient had instent restenosis of the study stent.The patient was enrolled in the (b)(6) study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion one was located in the right leg mid superficial femoral artery (sfa) extending to the distal sfa with 70% stenosis and was 106 mm long with a proximal reference vessel diameter of 5.3 mm and distal vessel diameter of 5.8 mm and was classified as tasc ii b lesion.The lesion was treated with pre-dilatation and a 7.00x120mm study stent was placed.Following post-dilatation, residual stenosis was 19%.On (b)(6) 2017, 368 days post index procedure, during the 12 month study specific follow up, dus was performed and the subject was diagnosed with 50-99% instent restenosis of the study stent placed in the right sfa.On (b)(6) 2018, during the 24 month study specific follow up, dus was performed and the subject was diagnosed with 50-99% instent restenosis of the study stent placed in the right sfa.No reported action was taken.

• Brand Name: ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8061360
• MDR Text Key: 126915398
• Report Number: 2134265-2018-62747
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 18766104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR